Routine and Deferred Dialysis Initiation (RADDI)

Peking University

Status: Unknown

Conditions: Chronic Kidney Disease

Treatments: Other: Algorithm for deferred dialysis intervention; Other: Algorithm for routine dialysis intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT02423655

201502010

Details and patient eligibility

About

This study evaluates the efficacy and safety of deferred dialysis initiation in Chinese population. 16 tertiary hospitals across China will be randomly assigned into routine and deferred dialysis groups.

Full description

The timing for initiating dialysis for progressive chronic kidney disease (CKD) patients is an important issue yet is not well established. There is a strong trend to early dialysis initiation for end stage renal disease (ESRD) patients over the past decades. However, observational data found that early initiation seemed to produce no benefit but additional burden to patients and the health care system. The IDEAL study, the only randomized, controlled trial (RCT) on this issue, found that all-cause mortality, comorbidities and quality of life had no difference between early (glomerular filtration rate, GFR 10-14ml/min/1.73m2) and late (GFR 5-7ml/min/1.73m2) dialysis starters. However there was a big limitation in this study that the difference for average GFR between two groups (12 ml/min/1.73 m2 vs. 9.8 ml/min/1.73m2) was not so separate. Recently, the Canadian Society of Nephrology have released a clinical practice guideline on this issue. The guideline recommends an "intent-to-defer" approach for dialysis initiation and to initiate dialysis in the absence of symptoms in patients with an estimated GFR of 6 ml/min /1.73 m2 or less. In this guideline the specialists also express that the optimal management of patients with an estimated GFR of 6 ml/min per 1.73 m2 or less is based on limited data. There is a gap in knowledge. This research will further evaluate the efficacy and safety of deferred dialysis initiation and fill in this gap. In this study, algorithms will be adopted to determine the timing of dialysis initiation for both routine and deferred dialiysis groups, and the only difference in these two algorithms is the GFR level to initiate dialysis (7 Vs. <5 ml/min per 1.73 m2). The theory that blood access (arteriovenous fistulas) can be timely prepared according to the past GFR decline trajectory will also be tested.

Enrollment: 1,049 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Nondialysis-dependent stable CKD stage 4-5 patients (eGFR>7ml/min /1.73 m2)
2. Willing to choose dialysis as his renal replacement therapy method
3. Heart function: grade I or II (NYHA Functional Classification)

Exclusion criteria

1. The life expectancy of patients is estimated to be short (due to causes other than kidney disease);
2. Acute infection occurred in one month;
3. Myocardial infarction, NYHA class IV or stroke events within 3 months;
4. Uncontrolled malignancy;
5. Active viral hepatitis;
6. Active rheumatic disease;
7. Pregnant women, women intending to conceive after enrollment or breastfeeding woman;
8. Planning to take kidney transplantation within the study period;
9. With indices of emergency dialysis;
10. eGFR less than 7 ml/min/1.73m2 in first visit;
11. Under other clinical studies which has an impact on this study;
12. Unable to provide written informed consent.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

1,049 participants in 2 patient groups

Deffered Dialysis Initiation

Experimental group

Description:

Algorithm for deferred dialysis intervention: initiating dialysis in the absence of symptoms in patients with an eGFR of 5 ml/min /1.73 m2 or less

Treatment:

Other: Algorithm for deferred dialysis intervention

Routine dialysis Initiation

Active Comparator group

Description:

Algorithm for routine dialysis intervention: initiating dialysis in the absence of symptoms in patients with an eGFR of 7 ml/min /1.73 m2 (which is the average GFR for patients in Beijing to start dialysis )

Treatment:

Other: Algorithm for routine dialysis intervention